CoLucid Pharmaceuticals, Inc. Release: New Study Shows That Majority of Acute Migraine Patients Have Cardiovascular Disease Risk Factors and One Third Have Cardiovascular Disease

DURHAM, N.C., Dec. 20, 2012 /PRNewswire/ -- Analysis of the American Migraine Prevention and Prevalence (AMPP) study database indicate that a substantial proportion of persons with migraine also have cardiovascular events, cardiovascular disease (CVD), or CVD risk factors. These conclusions from the AMPP study are based upon an evaluation of 6,723 people with migraine, identified by screening a representative sample of over 160,000 Americans. The study showed that:

18% of migraineurs had a contraindication to triptans based on cardiovascular events, including heart attack, stroke, claudication, or angina, or cardiovascular procedures such as stenting or bypass surgery.

The overall risk of cardiovascular events and procedures was only slightly higher in men (19.5%) than women (18.0%).

Risk increased with age from 11% of those younger than 40, to 19.7% of those age 40-59 and 34.0% for those over 60.

The most widely used prescription drugs for migraine come from the triptan class, as exemplified by sumatriptan and rizatriptan. Because triptans constrict blood vessels, they are contraindicated in patients with cardiovascular, cerebrovascular or peripheral vascular disease. In addition, the FDA recommends that migraine patients with CVD risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, women with surgical or physiological menopause, men over 40 years of age) should be evaluated for silent myocardial ischemia before receiving a triptan, and in some cases, have their first dose administered in a medically supervised setting. "Overall, we estimate that there are 5.2 million Americans over age 18 with migraine for whom triptan medications are contraindicated," said Dawn Buse, PhD, Associate Professor of Neurology at Albert Einstein College of Medicine and study co-investigator. "In addition, many adults with migraine have risk factors for CVD that mandate caution in using triptans."

"Despite their efficacy, only a small percentage of migraine attacks are treated with triptans. Low rates of treatment are due in part to cardiovascular events and disease and in part to worry about CVD on the part of prescribing clinicians and people with migraine. Highly effective and safe treatments free of cardiovascular risk would be a welcome addition to the therapeutic armamentarium," remarked Richard Lipton, MD, Professor and Vice Chair of Neurology, Albert Einstein College of Medicine and Director, Montefiore Headache Center and study primary investigator.

Thomas P. Mathers, CEO of CoLucid Pharmaceuticals, Inc., noted that "These new findings underscore the significant unmet need of migraineurs who cannot, or are unwilling to, take triptans due to cardiovascular safety concerns." He added that "These patients need access to effective, safe medicines that lack the vasoconstrictor activity of current therapies. Lasmiditan is a new therapy entering Phase 3 clinical development to address this unmet need."

Sponsorship: The American Migraine Prevalence and Prevention Study is funded through a research grant to the National Headache Foundation from Ortho-McNeil Neurologics, Inc., Titusville, NJ. Additional analyses were supported by a grant from CoLucid Pharmaceuticals (Durham, NC), to the National Headache Foundation.

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache. Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans. Lasmiditan is a member of a novel chemical class called "ditans" and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway. Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans. For more information, please visit CoLucid at www.colucid.com.